Overview
SIST EN ISO 18778:2023 (identical to EN ISO 18778:2022 / ISO 18778:2022) specifies particular requirements for the basic safety and essential performance of infant cardiorespiratory monitors. The scope covers monitors intended to measure cardiorespiratory parameters in sleeping or resting children under three years of age, including devices intended for:
- home healthcare use,
- operation by a lay operator (parents, caregivers),
- transit‑operable use (portable or transport scenarios).
The standard also applies to manufacturer‑intended accessories whose characteristics can affect monitor safety or performance (for example, probes, cables, distributed alarm systems). It supersedes the 2009 edition.
Key topics and technical requirements
ISO 18778:2022 structures requirements that support safe design, testing and use without prescribing specific numerical clinical limits. Major technical areas include:
- General safety and essential performance - definition of essential performance and guidance for design to maintain it.
- Testing and classification - pre‑use checks, testing procedures, classification of equipment and accessories.
- Identification, marking and documentation - labelling, instructions for use (separate guidance for lay operators and healthcare professionals), warnings, start‑up and maintenance instructions.
- Accuracy and alarm behavior - requirements for accuracy of controls and instruments, cardiorespiratory monitoring (direct respiration, indirect heart rate, pulse oximetry), apnoea alarm conditions and sensor fault handling, and clinical performance evaluation.
- Usability and training - emphasis on user interface, instructions for lay use and training needs.
- Electrical, mechanical and thermal protection - protection against electrical hazards, mechanical instability, excessive temperatures and radiation.
- Biocompatibility, cleaning & sterilization - requirements for materials and reprocessing where applicable.
- Programmable electrical medical systems (PEMS) and electromagnetic compatibility (EMC) - software/systematic risk control and EMC testing.
- Accessories and system connections - labelling, functional connections and distributed alarm systems.
Practical applications
Manufacturers, designers and test laboratories use ISO 18778 to:
- Design and validate infant cardiorespiratory monitors for home and transit use.
- Prepare technical documentation, labeling and user manuals suitable for lay caregivers.
- Define testing protocols for alarms, sensor faults and clinical performance evaluation.
- Ensure safe interoperability with accessories (probes, cables, alarm systems).
- Demonstrate compliance with European/national regulatory requirements where EN ISO adoption is recognized.
Who should use this standard
- Medical device manufacturers (R&D, QA/RA teams)
- Test and certification laboratories
- Regulatory and compliance professionals
- Procurement specialists in healthcare and homecare
- Clinical engineers and biomedical device evaluators
- User‑training developers and healthcare providers
Related standards (context)
ISO 18778 complements broader medical electrical device standards addressing general ME equipment safety, EMC, software lifecycle and clinical evaluation. For national adoption, consult CEN/CENELEC/ISO publications and local regulatory guidance.